Label: ARTHRITIS CREAM- trolamine salicylate 10% cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated September 15, 2022

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  • ACTIVE INGREDIENT

    Trolamine Salicylate 10%

  • PURPOSE

    Topical analgesic

  • INDICATIONS & USAGE

    Temporarily relieves minor pain associated with:

    Arthritis

    Simple backache

    muscle strains

    sprains

    bruises

  • WARNINGS

    For external use only

    Allergy Alert:

    If prone to allergic reaction from aspirin or salicylates, consult a doctor before use.

    When using the product

    use only as directed

    do not bandage tightly or use with a heating pad

    avoid contact with eyes or mucous membranes

    do not apply to wounds or damaged skin

    Stop use and ask doctor if

    condition worsens

    symptoms persist for more than 7 days or clear up and occur again within few days

    redness is present

    irritation develops

    If pregnant or breast feeding, ask a health professional before use.

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control right away. (1-800-222-1222)

  • DOSAGE & ADMINISTRATION

    Directions:

    adults and children over 12 years:

    apply generously to affected area

    massage into painful area until thoroughly absorbed into skin

    repeat as necessary, but not more than 4 times daily

    Children 12 years and younger: ask a doctor

  • OTHER SAFETY INFORMATION

    Store at 20° - 25°C (68° - 77°F)

  • INACTIVE INGREDIENT

    Aloe barbadensis leaf juice, cetyl alcohol, glycerin, mineral oil, phenoxyethanol, stearic acid, triethanolamine, water, xanthan gum

  • PRINCIPAL DISPLAY PANEL

    Package LabelPackage Carton

  • INGREDIENTS AND APPEARANCE
    ARTHRITIS CREAM 
    trolamine salicylate 10% cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51316-990
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TROLAMINE SALICYLATE (UNII: H8O4040BHD) (SALICYLIC ACID - UNII:O414PZ4LPZ) TROLAMINE SALICYLATE10 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    MINERAL OIL (UNII: T5L8T28FGP)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51316-990-1085 g in 1 TUBE; Type 0: Not a Combination Product09/15/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34809/15/2022
    Labeler - CVS (062312574)
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